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在越南南部,用于钩端螺旋体病的快速血清学检测价值有限。

Rapid serological assays for leptospirosis are of limited value in southern Vietnam.

作者信息

Wagenaar J F P, Falke T H F, Nam N V, Binh T Q, Smits H L, Cobelens F G J, de Vries P J

机构信息

Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Center F4-217, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

出版信息

Ann Trop Med Parasitol. 2004 Dec;98(8):843-50. doi: 10.1179/000349804X3207.

Abstract

Leptospirosis, although ubiquitous and potentially lethal, is often not diagnosed. The seroprevalence of anti-Leptospira antibodies and the utility of two rapid tests for the serodiagnosis of the disease were studied in Binh Thuan, an area in southern Vietnam with favourable conditions for Leptospira. In an initial survey, blood samples from 44 patients with undifferentiated fever and 83 healthy subjects were each examined for anti- Leptospira antibodies using three tests: an ELISA; a latex card-agglutination test (Dri Dot); and a lateral-flow assay (LeptoTek Lateral Flow). In the ELISA, samples from 35% of the healthy subjects and 40% of the febrile patients were found to have titres of anti- Leptospira IgM of at least 1:80. Only one of the 13 patients checked again, in ELISA, 3 weeks later, showed the marked increase in IgM titre that is indicative of acute leptospirosis. In the initial survey, although the positive results of the lateral-flow assay, applied to whole blood and serum, showed a good agreement with those of the ELISA (kappa = 0.743), the results of the lateral-flow assay were often indeterminate. The card-agglutination test was more specific. The overall agreement between the results of the rapid tests and those of the ELISA was generally poor. When the samples classified as 'indeterminate' in the lateral-flow assay were considered positive, the maximum kappa-value for this assay applied to whole blood was only 0.512. In conclusion, it appears that high seroprevalences of anti- Leptospira IgM and low incidences of acute leptospirosis limit the diagnostic value of the rapid tests that were investigated. The lateral-flow assay is not specific enough. The card-agglutination test is possibly better but, because of the low incidence, its sensitivity could not be evaluated adequately in the present study.

摘要

钩端螺旋体病虽然普遍存在且可能致命,但往往无法得到诊断。在越南南部条件适宜钩端螺旋体生存的平顺省,对钩端螺旋体抗体的血清流行率以及两种用于该病血清学诊断的快速检测方法的效用进行了研究。在初步调查中,对44例不明原因发热患者和83名健康受试者的血液样本分别使用三种检测方法检测抗钩端螺旋体抗体:酶联免疫吸附测定(ELISA);乳胶卡片凝集试验(Dri Dot);以及侧向流动分析(LeptoTek侧向流动法)。在ELISA检测中,发现35%的健康受试者和40%的发热患者样本的抗钩端螺旋体IgM滴度至少为1:80。3周后再次进行ELISA检测的13例患者中,只有1例显示IgM滴度显著升高,提示急性钩端螺旋体病。在初步调查中,尽管应用于全血和血清的侧向流动分析的阳性结果与ELISA结果显示出良好的一致性(kappa值 = 0.743),但其结果往往不确定。卡片凝集试验更具特异性。快速检测结果与ELISA结果之间的总体一致性通常较差。当将侧向流动分析中分类为“不确定”的样本视为阳性时,该方法应用于全血时的最大kappa值仅为0.512。总之,抗钩端螺旋体IgM的高血清流行率和急性钩端螺旋体病的低发病率似乎限制了所研究的快速检测方法的诊断价值。侧向流动分析特异性不够。卡片凝集试验可能更好,但由于发病率低,在本研究中无法充分评估其敏感性。

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